EP4039247A3 - Formulation sublinguale de riluzole - Google Patents

Formulation sublinguale de riluzole Download PDF

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Publication number
EP4039247A3
EP4039247A3 EP21169884.0A EP21169884A EP4039247A3 EP 4039247 A3 EP4039247 A3 EP 4039247A3 EP 21169884 A EP21169884 A EP 21169884A EP 4039247 A3 EP4039247 A3 EP 4039247A3
Authority
EP
European Patent Office
Prior art keywords
riluzole
sublingual formulation
sublingual
disclosed
formulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21169884.0A
Other languages
German (de)
English (en)
Other versions
EP4039247A2 (fr
Inventor
Vladimir Coric
Robert M. BERMAN
Ronald Samuel VLADYKA
Amgad SALEH
Danny Yu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biohaven Pharmaceutical Holding Co Ltd
Original Assignee
Biohaven Pharmaceutical Holding Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biohaven Pharmaceutical Holding Co Ltd filed Critical Biohaven Pharmaceutical Holding Co Ltd
Publication of EP4039247A2 publication Critical patent/EP4039247A2/fr
Publication of EP4039247A3 publication Critical patent/EP4039247A3/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/428Thiazoles condensed with carbocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Psychiatry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Psychology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP21169884.0A 2014-11-21 2015-11-17 Formulation sublinguale de riluzole Pending EP4039247A3 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462083094P 2014-11-21 2014-11-21
EP19186196.2A EP3616686B8 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole
PCT/US2015/061114 WO2016081472A1 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole
EP15823415.3A EP3220891B1 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
EP15823415.3A Division EP3220891B1 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole
EP19186196.2A Division-Into EP3616686B8 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole
EP19186196.2A Division EP3616686B8 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole

Publications (2)

Publication Number Publication Date
EP4039247A2 EP4039247A2 (fr) 2022-08-10
EP4039247A3 true EP4039247A3 (fr) 2022-11-16

Family

ID=55085882

Family Applications (3)

Application Number Title Priority Date Filing Date
EP19186196.2A Active EP3616686B8 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole
EP21169884.0A Pending EP4039247A3 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole
EP15823415.3A Active EP3220891B1 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP19186196.2A Active EP3616686B8 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP15823415.3A Active EP3220891B1 (fr) 2014-11-21 2015-11-17 Formulation sublinguale de riluzole

Country Status (24)

Country Link
US (2) US11660267B2 (fr)
EP (3) EP3616686B8 (fr)
JP (3) JP6753860B2 (fr)
KR (2) KR20230135183A (fr)
CN (1) CN107249567B (fr)
AU (2) AU2015350148B2 (fr)
BR (1) BR112017010423B1 (fr)
CA (1) CA2967662A1 (fr)
CY (1) CY1122469T1 (fr)
DK (1) DK3220891T3 (fr)
EA (1) EA038518B1 (fr)
ES (2) ES2751300T3 (fr)
HR (1) HRP20191892T8 (fr)
HU (1) HUE046869T2 (fr)
IL (2) IL252285B (fr)
LT (1) LT3220891T (fr)
MX (1) MX368838B (fr)
PH (1) PH12017500934A1 (fr)
PL (1) PL3220891T3 (fr)
PT (1) PT3220891T (fr)
RS (1) RS59490B1 (fr)
SG (1) SG11201703896QA (fr)
SI (1) SI3220891T1 (fr)
WO (1) WO2016081472A1 (fr)

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CA3038979A1 (fr) 2016-10-11 2018-04-19 Arvinas, Inc. Composes et procedes pour la degradation ciblee du recepteur des androgenes
JP7354123B2 (ja) 2018-02-21 2023-10-02 エイアイ・セラピューティクス・インコーポレーテッド アピリモドとグルタミン酸作動薬を用いた併用療法
EP3801626A4 (fr) * 2018-05-27 2022-02-23 Biohaven Pharmaceutical Holding Company Ltd. Utilisation de comprimés orodispersibles à base de riluzole pour le traitement de maladies
CA3109769A1 (fr) * 2018-08-16 2020-02-20 Biohaven Therapeutics Ltd. Utilisation de comprimes orodispersibles a base de riluzole pour le traitement de maladies
JP2022553954A (ja) * 2019-10-22 2022-12-27 アルビナス・オペレーションズ・インコーポレイテッド 前立腺癌を治療する方法
KR20230015933A (ko) 2020-05-09 2023-01-31 아비나스 오퍼레이션스, 인코포레이티드 이작용성 화합물, 이작용성 화합물의 초순수 형태, 및 이를 포함하는 투여 형태를 제조하는 방법
US20240016783A1 (en) * 2020-10-05 2024-01-18 Icahn School Of Medicine At Mount Sinai Riluzole for the treatment of alzheimer's disease
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CN113876735B (zh) * 2021-10-20 2023-05-12 陇南市第一人民医院 一种利鲁唑微球制剂及其制备方法
KR102625977B1 (ko) 2021-11-24 2024-01-17 부산대학교 산학협력단 리루졸을 유효성분으로 포함하는 염증성 장질환 예방 또는 치료용 조성물

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WO2010102923A2 (fr) * 2009-03-13 2010-09-16 Italfarmaco Spa Suspensions aqueuses de riluzole
WO2016140878A2 (fr) * 2015-03-03 2016-09-09 Biohaven Pharmaceutical Holding Company Ltd. Promédicaments de riluzole et leur procédé d'utilisation

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WO2010102923A2 (fr) * 2009-03-13 2010-09-16 Italfarmaco Spa Suspensions aqueuses de riluzole
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Also Published As

Publication number Publication date
HRP20191892T1 (hr) 2020-01-10
IL278188A (en) 2020-11-30
US20210038499A1 (en) 2021-02-11
EP3616686B8 (fr) 2021-06-23
AU2021201034B2 (en) 2023-07-06
BR112017010423B1 (pt) 2023-09-26
US11660267B2 (en) 2023-05-30
EP3220891A1 (fr) 2017-09-27
WO2016081472A1 (fr) 2016-05-26
HRP20191892T8 (hr) 2020-09-18
EP4039247A2 (fr) 2022-08-10
SI3220891T1 (sl) 2020-02-28
CY1122469T1 (el) 2021-01-27
MX2017006446A (es) 2018-02-12
LT3220891T (lt) 2019-11-11
JP2021001173A (ja) 2021-01-07
MX368838B (es) 2019-10-18
HUE046869T2 (hu) 2020-04-28
ES2751300T3 (es) 2020-03-31
AU2015350148B2 (en) 2020-11-26
RS59490B1 (sr) 2019-12-31
IL252285B (en) 2020-10-29
CN107249567A (zh) 2017-10-13
KR102580378B1 (ko) 2023-09-19
JP6753860B2 (ja) 2020-09-09
EA038518B1 (ru) 2021-09-09
EP3616686B1 (fr) 2021-05-19
PT3220891T (pt) 2019-10-31
IL252285A0 (en) 2017-07-31
US20180153794A1 (en) 2018-06-07
BR112017010423A2 (pt) 2017-12-26
JP2023065398A (ja) 2023-05-12
AU2015350148A1 (en) 2017-06-15
SG11201703896QA (en) 2017-06-29
EP3616686A1 (fr) 2020-03-04
EA201790958A1 (ru) 2018-01-31
CA2967662A1 (fr) 2016-05-26
EP3220891B1 (fr) 2019-07-24
PL3220891T3 (pl) 2020-08-24
AU2021201034A1 (en) 2021-03-11
JP2017535613A (ja) 2017-11-30
KR20170137032A (ko) 2017-12-12
DK3220891T3 (da) 2019-11-04
KR20230135183A (ko) 2023-09-22
ES2882783T3 (es) 2021-12-02
PH12017500934A1 (en) 2017-11-20
CN107249567B (zh) 2021-08-03

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